BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2924863 · Received January 17, 2013

    Report

    Report Number
    9612169-2013-00001
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    September 22, 2012
    Report Date
    December 17, 2012
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE POSTOPERATIVE RESULTS WERE NOT SATISFACTORY AND THE PATIENT EXPERIENCED SAND SENSATION AND WATERING. MEDICAL RECORDS WERE RECEIVED AND REVIEWED WHICH INDICATED THE PATIENT REPORTED SAND SENSATION, WATERING AND BLURRED VISION AT THE ONE MONTH POSTOPERATIVE VISIT. AT TWO MONTHS POSTOPERATIVE, THE PATIENT REPORTED SEEING A "LITTLE CIRCLE IN THE EYE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26246 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN6AD1 21051371

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other DUOVISC| MYDRIATICUM| NEOSYNEPHRINE 5% BEGINNING| CIFLOX